RayStation standalone software radiation therapy recall
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
Why was RayStation standalone software radiation therapy recalled?
When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version number: 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 , 10.1.0.613
- Product
- RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- N/A
- Distribution
- Domestic: TN
- Recall date
- May 26, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)